Morbid ObesityNCT00283374
Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
An observational study of Morbid Obesity and Metabolic Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 17 sites in 3 countries.
Trial summary
Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Morbid Obesity, Metabolic Disease
- What is being tested?
- Laparoscopic Roux-en-Y Gastric Bypass
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Oct 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects must be approved by both insurance and site standard of care to undergo the Roux-en-Y gastric bypass procedure
- Male and Female Candidates for Roux-en-Y Bariatric Surgery
- Must be diagnosed with Metabolic Syndrome; having abdominal obesity and at least 2 other features of the syndrome per IDF (International Diabetes Foundation)
- Obese control group:Subjects should be obese and should not have any other features of metabolic syndrome.
Who cannot join
- Any subjects with prior bariatric surgery
- No other major surgery within the last 6 months
- Diabetes on treatment with hypoglycemic medication in the previous 6 months
- Other exclusions apply
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States10 sites
Study site
Atlanta, Georgia, 30322
Study site
Boston, Massachusetts, 02111
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75390-9156
Study site
Indianapolis, Indiana, 46278
Study site
Irvine, California, 92697-1050
Study site
Minneapolis, Minnesota, 55455
Study site
Orange, California, 92868
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Pittsburgh, Pennsylvania, 15240
Sweden4 sites
Study site
Gothenburg, 413 45
Study site
Stockholm, 116 91
Study site
Stockholm, 141 86
Study site
Stockholm, 182- 88
Italy3 sites
Study site
Aosta, 11100
Study site
Pisa, 56127
Study site
Roma, 00168
About this study
Official title: A Prospective, Longitudinal Multicenter, Nontreatment, Exploratory Biomarker Study of Metabolic Syndrome in Subjects Undergoing Laparoscopic Roux-En-Y Gastric Bypass Bariatric Syndrome
Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease.
Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and thought to play a major role in the metabolic disturbances associated with obesity and metabolic syndrome.
Read more
Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and is associated with obesity, insulin resistance and metabolic syndrome.
Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.
- Conditions
- Morbid Obesity, Metabolic Disease
- Being tested
- Laparoscopic Roux-en-Y Gastric Bypass
- Keywords
- Metabolic Syndrome, Obesity, Nonalcoholic fatty liver disease, Nonalcoholic steatohepatitis, Bariatric Surgery
- Medical subject headings
- Obesity, Morbid, Metabolic Diseases, Metabolic Syndrome, Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux-en-Y Gastric BypassProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Italy, decresg@wyeth.comTrial Manager, Principal investigator, For Sweden, MedInfoNord@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283374
- Sponsor's protocol ID
- 9804Z1-900
- Status last verified
- May 2006
- First submitted
- 25 Jan 2006
- Last updated
- 18 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Longitudinal Multicenter, Nontreatment, Exploratory Biomarker Study of Metabolic Syndrome in Subjects Undergoing Laparoscopic Roux-En-Y Gastric Bypass Bariatric Syndrome
- ClinicalTrials.gov ID
- NCT00283374
- Acronym / sponsor ID
- 9804Z1-900
- Conditions
- Morbid Obesity, Metabolic Disease
- Keywords
- Metabolic Syndrome, Obesity, Nonalcoholic fatty liver disease, Nonalcoholic steatohepatitis, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 120 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- First posted
- 27 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease.
Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and thought to play a major role in the metabolic disturbances associated with obesity and metabolic syndrome.
Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and is associated with obesity, insulin resistance and metabolic syndrome.
Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All subjects must be approved by both insurance and site standard of care to undergo the Roux-en-Y gastric bypass procedure
- Male and Female Candidates for Roux-en-Y Bariatric Surgery
- Must be diagnosed with Metabolic Syndrome; having abdominal obesity and at least 2 other features of the syndrome per IDF (International Diabetes Foundation)
- Obese control group:Subjects should be obese and should not have any other features of metabolic syndrome.
Key exclusion criteria (4 listed)
- Any subjects with prior bariatric surgery
- No other major surgery within the last 6 months
- Diabetes on treatment with hypoglycemic medication in the previous 6 months
- Other exclusions apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Roux-en-Y Gastric Bypass | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Italy, decresg@wyeth.com
Trial Manager principal investigator
For Sweden, MedInfoNord@wyeth.com
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Metabolic Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Sweden, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2006.